Subject:
Gonadotropin-Releasing Hormone (GnRH) Receptor Antagonist [Degarelix (Firmagon™)]
Description:
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IMPORTANT NOTE:
The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.
Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.
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Degarelix for injection (Firmagon™) binds reversibly to the pituitary gonadotropin-releasing hormone (GnRH) receptors, thereby reducing the release of gonadotropins and consequently testosterone. In December 2008, degarelix was FDA-approved for the treatment of patients with advanced prostate cancer. Degarelix is unique in its mechanism of action by allowing it to produce a rapid and sustained reduction of testosterone to castration level from day 3, which is much faster than other drugs indicated for advanced prostate cancer.
Policy:
(NOTE: For Medicare Advantage, please refer to the Medicare coverage section below for coverage guidance.)
I. The prescriber is a specialist in the area of the patient’s diagnosis (e.g. oncologist) or has consulted with a specialist in the area of the patient’s diagnosis.
II. Degarelix (Firmagon™) is medically necessary for the FDA-approved indication of advanced prostate cancer for members that are 18 years and older.
III. When considered medically necessary, degarelix (Firmagon™) therapy will be approved for 1 year at the FDA-recommended dose:
a. starting dose of 240 mg given as two subcutaneous injections of 120mg each
b. maintenance dose of 80 mg every 28 days given as a subcutaneous injection, with first dose given 28 days after starting dose
[INFORMATIONAL NOTE: As per the FDA approved package insert, monthly monitoring of testosterone is recommended until castration levels are achieved followed by every-other-month monitoring.
Based on the FDA approved package insert, degarelix (FirmagonTM) may prolong the QT interval, risks and benefits should be weighed in patients with congenital long QT syndrome, congestive heart failure, frequent electrolyte abnormalities, and in those taking drugs known to prolong the QT interval.]
IV. Degarelix (Firmagon™) is medically necessary for annual renewal when member meets ALL of the following criteria:
1. Tumor response with stabilization of disease or decrease in size of tumor or tumor spread; AND
2. Absence of unacceptable toxicity from the drug (i.e. hypersensitivity reactions, QTc prolongation)
V. Degarelix (Firmagon™) is medically necessary for the following off-label uses:
- Prostate Cancer
- Used for progressive castration-naïve disease
- As a single agent for M0 or M1 disease
- In combination with docetaxel with concurrent steroid for M1 disease
- In combination with abiraterone and prednisone for M1 disease
- As a single agent with external beam radiation therapy (EBRT) to the primary tumor for low volume M1 disease
- Used for M0 or M1 castration-recurrent disease as androgen deprivation therapy (ADT) to maintain castrate serum levels of testosterone (<50ng/dL)
- Androgen deprivation therapy (ADT) as a single agent for M0 PSA persistence/recurrence
- after radical prostatectomy in combination with external beam radiation therapy (EBRT) if studies negative for distant metastatic disease
- or positive digital rectal examination (DRE) after EBRT if biopsy negative and studies negative for distant metastatic disease
- or positive DRE after EBRT in patients who are not candidates for local therapy (especially if bone scan positive)
- Adjuvant androgen deprivation therapy (ADT) as a single agent with or without external beam radiation therapy (EBRT) if lymph node metastasis found during pelvic lymph node dissection (PLND) for patients
- in the favorable or unfavorable intermediate risk group and ≥10 year expected survival
- in the high or very high risk groups and >5 year expected survival
- Adjuvant androgen deprivation therapy (ADT) as a single agent for 6 months with external beam radiation therapy (EBRT) if adverse features (i.e. positive margins, seminal vesicle invasion, extracapsular extension, or detectable PSA) noted after radical prostatectomy (RP) for patients
- in the very low risk group and ≥20 year expected survival
- in the low risk group and ≥10 year expected survival
- with or without pelvic lymph node dissection (PLND) in the favorable or unfavorable intermediate risk group and ≥10 year expected survival
- with or without PLND in the high risk group and >5 year expected survival or symptomatic
- Androgen deprivation therapy (ADT) as a single agent if life expectancy ≤5 years and asymptomatic
- in selected patients with high or very high risk disease where complications such as hydronephrosis or metastasis can be expected within 5 years
- in patients with regional risk disease
- Initial androgen deprivation therapy (ADT) as a single agent if life expectancy >5 years or symptomatic
- for 4 months in combination with external beam radiation therapy (EBRT) with or without brachytherapy for patients in the unfavorable intermediate risk group
- for 1.5-3 years in combination with EBRT for patients in the high or very high risk group
- for 1-3 years in combination with EBRT and brachytherapy for patients in the high or very high risk group
- in combination with EBRT with or without abiraterone and prednisone for patients in the regional risk group
- with or without abiraterone and prednisone for patients in the regional risk group
VI. Degarelix (Firmagon™) is considered investigational in other conditions including, but not limited to, the following:
a. Infertility in females: synchronization of egg sacs
b. Benign Prostatic Hyperplasia
c. Endometriosis
d. Breast Cancer
Medicare Coverage:
There is no National Coverage Determination (NCD) or Local Coverage Determination (LCD) for jurisdiction JL for Gonadotropin-Releasing Hormone (GnRH) Receptor Antagonist [Degarelix (Firmagon™)]. Gonadotropin-Releasing Hormone (GnRH) Receptor Antagonist [Degarelix (Firmagon™)] is administered subcutaneously. Per Local Coverage Article A53127, Drugs ADMINISTERED subcutaneously are considered to be usually SELF-ADMINISTERED. If a drug is SELF-ADMINISTERED by more than 50 percent of Medicare beneficiaries, the drug is excluded from coverage under Medicare Part B. Therefore, for Medicare Advantage Products, Gonadotropin-Releasing Hormone (GnRH) Receptor Antagonist [Degarelix (Firmagon™)] is noncovered.
For members with a Medicare drug plan (Part D) Gonadotropin-Releasing Hormone (GnRH) Receptor Antagonist [Degarelix (Firmagon™) may be covered under that plan.
However, Medicare covers drugs that are furnished “incident to” a physician’s service provided that the drugs are medically reasonable and necessary, approved by the Food and Drug Administration (FDA) and are not usually administered by the patients who take them. Therefore, Medicare Advantage Products will cover Gonadotropin-Releasing Hormone (GnRH) Receptor Antagonist [Degarelix (Firmagon™) when the Horizon BCBSNJ Medical Policy criteria is met AND the drug is furnished and administered by a licensed medical provider as part of a physician service.
Medicaid Coverage
For Horizon NJ Health members, please follow this link for the corresponding HNJH drug policy https://services3.horizon-bcbsnj.com/ddn/NJhealthWeb.nsf
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Horizon BCBSNJ Medical Policy Development Process:
This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.
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Index:
Gonadotropin-Releasing Hormone (GnRH) Receptor Antagonist [Degarelix (Firmagon™)]
Degarelix (Firmagon)
Firmagon (Degarelix)
GnRH Receptor Antagonist
References:
1. Ferring Pharmaceuticals Inc. Degarelix (Firmagon™) prescribing information. Parsipanny, NJ; June 2016.
2. Micromedex Health Series. Thomson Gateway. [Available at: http://www.thomsonhc.com/hcs/librarian/PFPUI/AH1fgpoxqU9YRhttp://www.micromedexsolutions.com/micromedex2/librarian/ND_T/evidencexpert/ND_PR/evidencexpert/CS/6C95D7/ND_AppProduct/evidencexpert/DUPLICATIONSHIELDSYNC/714DF8/ND_PG/evidencexpert/ND_B/evidencexpert/ND_P/evidencexpert/PFActionId/evidencexpert.DisplayDrugdexDocument?docId=2768&contentSetId=31&title=Degarelix+Acetate&servicesTitle=Degarelix+Acetate&topicId=clinicalApplicationsSection&subtopicId=therapeuticUsesSection] Accessed on January 2020.
3. Clinical Trials.gov. Available at [http://clinicaltrials.gov]. Accessed on January 2020.
4. Klotz, L., Boccon-Gibod, L., et al. The efficacy and safety of degarelix: a 12-month, comparative, randomized, open-label, parallel-group phase III study in patients with prostate cancer. Brit J of Urology 2008;102:1531-1538.
5. Clinical Pharmacology. Available at: www.clinicalpharmacology.com. Accessed January 2020.
6. National Comprehensive Cancer Network (NCCN) Drugs and Biologics Compendium. Available at: http://www.nccn.org/professionals/drug_compendium/MatrixGenerator/Matrix.aspx?AID=353. Accessed. January 2020.
7. Nation Comprehensive Cancer Network. Prostate Cancer (Version 4.2019) https://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf. Accessed January 2020.
Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)
CPT*
HCPCS
* CPT only copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.
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Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.
The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy
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